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  1. Warning Letters

WARNING LETTER

Centennial Vapor MARCS-CMS 591340 —


Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco

Recipient:
Recipient Name
Andrew Rickert
Centennial Vapor

2323 E. Evans Ave.
Denver, CO 80210
United States

Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


SEP 27, 2019

 

info@centennialvapor.com

 

 

WARNING LETTER

 

Dear Mr. Rickert:

 

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed the website http://www.centennialvapor.com and determined that the e-liquid products listed on that site are manufactured and offered for sale or distribution to customers in the United States. 

 

FDA has also reviewed your submissions to the FDA and our records from inspections of Centennial Vapor and determined that Centennial Vapor manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products Centennial Vapor manufactures are offered for sale or distribution to customers in the United States.

 

Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, Centennial Vapor’s products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

 

Tobacco Product Sold to a Minor is Misbranded

 

FDA’s investigation of the website http://www.centennialvapor.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of http://www.centennialvapor.com, a person younger than 18 years of age purchased Cin City e-liquid product from your website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (ENDS) products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). 

 

Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. The product purchased by the person younger than 18 years of age from this website is a covered tobacco product. Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140. 

 

Because your Cin City e-liquid is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

 

E-Liquid Products with Packaging Without the Required Nicotine Warning Statement Are Misbranded

 

FDA’s investigation of the website http://www.centennialvapor.com, and FDA’s inspection of your establishment(s), revealed that packages for your Cin City, Cantaloupe, Chai Tea, Black Cherry, Crunchberry, Mtn. Vapor, Gummi Bears, and Cinnamon Toast Brunch e-liquid products, which you manufacture, package, sell, offer to sell, distribute, and/or import for sale or distribution into the United States, do not include the nicotine warning statement required by 21 C.F.R. § 1143.3(a). Under 21 C.F.R. § 1143.3(a), packages for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:

 

WARNING:  This product contains nicotine.  Nicotine is an addictive chemical.

 

For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the required warning statement on the package label (21 C.F.R. § 1143.3(a)(1)).  Under 21 C.F.R. § 1143.1, a “covered tobacco product” is defined as any tobacco product deemed to be subject to the FD&C Act under 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. The e-liquid products whose packages do not contain the required nicotine warning statement are “covered tobacco products.” Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your Cin City, Cantaloupe, Chai Tea, Black Cherry, Crunchberry, Mtn. Vapor, Gummi Bears, and Cinnamon Toast Brunch e-liquid products do not include the required nicotine warning statement on their packages, in violation of 21 C.F.R. § 1143.3(a), they are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

 

In addition, a tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product.

 

Because the product packages for your Cin City, Cantaloupe, Chai Tea, Black Cherry, Crunchberry, Mtn. Vapor, Gummi Bears, and Cinnamon Toast Brunch e-liquid products do not include the required nicotine warning statement, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). 

 

E-Liquid Products with Labeling and/or Advertising Without the Required Nicotine Warning Statement are Misbranded

 

FDA’s investigation of the website http://www.centennialvapor.com revealed that the labeling and/or advertising for e-liquid products that you manufacture, package, import, distribute or retail does not include the required nicotine warning statement, for example: Cinnamon Toast Brunch, Mtn. Vapor, Orange Cream, Skittlez, Gummi Bears, Crunchberry, Creme De Menthe, and Juicy Peach.  Under 21 C.F.R. § 1143.3(b), advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:

 

WARNING:  This product contains nicotine.  Nicotine is an addictive chemical.

 

For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for a tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(2).  As described above, your Cinnamon Toast Brunch, Mtn. Vapor, Orange Cream, Skittlez, Gummi Bears, Crunchberry, Creme De Menthe, and Juicy Peach e-liquid products are “covered tobacco products.” Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your website does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your Cinnamon Toast Brunch, Mtn. Vapor, Orange Cream, Skittlez, Gummi Bears, Crunchberry, Creme De Menthe, and Juicy Peach e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

 

In addition, a tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular.  A tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any state, its advertising is false or misleading in any particular.  Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product.  Because your website does not include the required nicotine warning statement for these products, your Cinnamon Toast Brunch, Mtn. Vapor, Orange Cream, Skittlez, Gummi Bears, Crunchberry, Creme De Menthe, and Juicy Peach e-liquid products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).  

 

The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). 

 

E-Liquid Products Manufactured in an Unregistered Establishment Are Misbranded

 

During inspection, FDA observed that you did not register your manufacturing establishment, located at 2323 E. Evans Ave. Denver, CO 80210, as required by section 905(d) of the FD&C Act (21 U.S.C. § 387e(d)). Specifically, section 905(d) states that “[e]very person…shall immediately register with the Secretary any additional establishment which that person owns or operates in any State and in which that person begins the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products.”

 

Because your establishment was not registered in violation of section 905(d) of the FD&C Act, your tobacco products that were manufactured, prepared, propagated, compounded, or processed at that establishment are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). In addition, the failure to register your establishment in accordance with section 905 is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)). 

 

E-Liquid Products Not Listed with FDA are Misbranded  

 

During inspection, FDA observed that your Cantaloupe and Tropical Thunder e-liquid products are not included in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)). Section 905(i)(3)(A) of the FD&C Act (21 U.S.C. § 387e(i)(3)(A)) requires that each person who registers with FDA under section 905 biannually report to FDA a list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the FDA under section 905(i).

 

Because your Cantaloupe and Tropical Thunder e-liquid products are not included in a product listing in violation of 905(i) of the FD&C Act (21 U.S.C. § 387e(i)), they are misbranded under section 903(a)(6) of the FD&C Act. The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act. Additionally, the failure to provide any information required by section 905(i) of the FD&C Act is a prohibited act under section 301(p) of the FD&C Act.

 

Failure to Submit Ingredient Listing is a Violation of the FD&C Act

 

FDA has observed that you have not provided an ingredient listing to FDA as required by Section 904(a)(1).  Section 904(a)(1) requires each tobacco product manufacturer or importer, or agents thereof to provide “a listing of ingredients, including tobacco, substances, compounds, and additives that are. . . added by the manufacturer to the tobacco, paper filter, or other part of each tobacco product by brand and by quantity in each brand and sub-brand.” 

 

Because you have not provided FDA with an ingredient listing in violation of section 904(a)(1), all tobacco products manufactured by Centennial Vapor are misbranded under section 903(a)(10)(A) of the FD&C Act (21 U.S.C. § 387d(a)(1). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). In addition, the failure to provide any information required by section 904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. § 331(q)(1)(B)). 

 

Additional Observations

  1. E-Liquid Products in Package Form Without a Statement of the Name and Place of Business May be Misbranded

FDA’s investigation of the website http://www.centennialvapor.com and inspection of your establishment(s) revealed that packages for your Cin City, Cantaloupe, Chai Tea, Black Cherry, Crunchberry, Mtn. Vapor, Gummi Bears, and Cinnamon Toast Brunch e-liquid products do not bear a label containing the place of business of the tobacco manufacturer, packer, or distributor as required under section 903(a)(2)(A) of the FD&C Act (21 U.S.C. § 387c(a)(2)(A)). Section 903(a)(2)(A) of the FD&C Act (21 U.S.C. § 387c(a)(2)(A)) states that a tobacco product in package form shall be deemed misbranded unless it bears a label containing the name and place of business of the tobacco product manufacturer, packer, or distributor.

 

Because the packages for your Cin City, Cantaloupe, Chai Tea, Black Cherry, Crunchberry, Mtn. Vapor, Gummi Bears, and Cinnamon Toast Brunch e-liquid products do not bear a label containing the place of business of the manufacturer, packer, or distributor they may be in violation of section 903(a)(2)(A) of the FD&C Act. The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a). 

  1. E-Liquid Products in Package Form Without the Statement “Sale only allowed in the United States” May be Misbranded

FDA’s investigation of the website http://www.centennialvapor.com and inspection of your establishment(s) revealed that packages for your Cin City, Cantaloupe, Chai Tea, Black Cherry, Crunchberry, Mtn. Vapor, Gummi Bears, and Cinnamon Toast Brunch e-liquid products do not bear a label containing the statement “Sale only allowed in the United States,” as required by section 903(a)(2)(D) of the FD&C Act (21 U.S.C. § 387c(a)(2)(D)) and section 920(a) (21 U.S.C. § 387t(a)). Specifically, section 903(a)(2)(D) of the FD&C Act (21 U.S.C. § 387c(a)(2)(D)) states that a tobacco product shall be deemed to be misbranded unless it bears a label containing the statement required under section 920(a); and section 920(a) provides that “the label, packaging, and shipping containers of tobacco products . . . for introduction or delivery for introduction into interstate commerce in the United States” shall bear the statement, “Sale only allowed in the United States.” 

 

Because your Cin City, Cantaloupe, Chai Tea, Black Cherry, Crunchberry, Mtn. Vapor, Gummi Bears, and Cinnamon Toast Brunch e-liquid products are not labeled with the statement “Sale only allowed in the United States,” they may be in violation of section 903(a)(2)(D) of the FD&C Act (21 U.S.C. §387c(a)(2)(D)). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)).

 

Conclusion and Requested Actions

 

The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to the ones stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 

 

It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising  comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. This includes labeling and/or advertising on http://www.centennialvapor.com, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that any adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.

 

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

 

Please note your reference number, ER1900032, in your response and direct your response to the following address:

 

DEM-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

 

If you have any questions about the content of this letter, please contact Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov.

 

Sincerely,
/S/

Ann Simoneau, J.D.

Director

Office of Compliance and Enforcement

Center for Tobacco Products

 

 

 

 

VIA UPS

 

 

cc:

 

Centennial Vapor

8586 E. Arapahoe Rd., Ste. 130

Centennial, CO  80112-1433